The Healthcare Transformation Group - made up of members Geisinger, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic and Mercy - has created a research and development team, to speed the implementation of a unique device identification system for medical devices.
The team is composed of physicians and clinical researchers from the five healthcare systems that make up the Healthcare Transformation Group, or HTG.
HTG was formed in 2010 as an action-oriented collaboration to share best practices and drive for needed positive change across the healthcare supply chain. The collaboration among the five health systems evolved as an extension of each member's involvement in healthcare's movement toward standards adoption, and HTG's first initiative was the implementation of GS1 Standards for their supply chains, the most widely used global system.
The new R&D team will advance the goals of the HTG, including the adoption of GS1 standards, and together accelerate the healthcare systems' work to implement a UDI system.
A UDI can identify devices, such as cardiac stents, pacemakers and orthopedic joint replacements through distribution and use.
The R&D team includes:
Joseph Drozda, Jr., MD, director of outcomes research, Mercy
Jove Graham, director of clinical research project development, Geisinger Center for Health Research, Geisinger Heath System
J. Brent Muhlestein, MD, cardiology, Intermountain Healthcare
Liz Paxton, director of surgical outcomes, Kaiser Permanente
Robert F. Rea, MD, cardiovascular diseases, Mayo Clinic
"We are focused more than ever on the full implementation of a UDI system in our industry," Drozda said, in a press statement. "Clinicians clearly see the value of the adoption of data standards."
"We also see the clear value and benefits of tracking medical devices and the positive impact this has on our patients and industry," Rea added.
Proponents of UDIs say being able to quickly identify a device that is recalled is critical.
"I don't think recall is all of it," Graham told Healthcare IT News. "But I think it's the easiest example to cite. Unlike a recall of a child's toy or something, you can just sort of look at it and figure whether you have the right one or not, when you're talking about an implant that's inside a patient's body, they obviously need more information to find out the immediate answer to the question, 'Does it affect me, or does it not affect me?'"
Graham explained that today many implants come with a wallet-sized card with some information about the device. But, some devices do not even have that.
"UDIs hopefully will really move things forward in terms of patients being able to know about their own medical devices," Graham said. "If an issue arises, if some problem is publicized with a particular type of device they can more quickly find out if it's something they need to deal with or if it is not affecting them."
Beyond the recalls, he said, there are other issues associated with medical devices, such as MRI safety or compatibility with other kinds of tests or procedures.
The R&D team will be working to establish a standard language and network of data sets within their healthcare systems. The project, which is an expansion of a FDA UDI demonstration project that is under way, will eventually provide a pathway to implement UDI into each HTG healthcare system's clinical processes, tracking devices end-to-end from manufacturer to research database.
As the FDA sees it, a UDI system can improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety.
The work undertaken by HTG can serve as a model for other healthcare organizations across the country, Graham said.
"We are moving forward," said R&D team member Paxton, so that ours and other healthcare systems and patients can benefit from broader adoption and use of GTINs (Global Trade Item Numbers), by manufacturers to build off our registry work so that all can better manage recalls going forward and further support our work around comparative effectiveness research."
Graham said the group expects to have made "some real strides" on the UDI project within this calendar year.
"The ability to manage devices through the supply chain, and create data sets for research and safety surveillance is critical," he said, noting that there's also a research aspect associated with UDI.
"From a research perspective," he said, there is a longer-term interest in bringing devices up to where drugs are right now in terms of the ability to really do sort of long-term surveillance and long-term studies - maybe observationally - on patients that get different types of products (to discover) what their long-term outcomes and what their long-term adverse events might be."